The Journal of Pediatrics
Volume 149, Issue 1, Supplement , Pages S3-S11 , July 2006

Conducting ethical research in pediatrics: A brief historical overview and review of pediatric regulations

  • Douglas S. Diekema, MD, MPH

      Affiliations

    • Corresponding Author InformationReprint requests: Dr Douglas S. Diekema, Treuman Katz Center for Pediatric Bioethics, MPW8-2, 1100 Olive Way, Suite 800, Seattle, Washington 98101.

References 

  1. Lederer SE , Grodin MA . Historical overview (Pediatric experimentation) . In:  Glanz LH editors. Children as Research Subjects (Science, Ethics, and Law) . New York:: Oxford University Press; 1994;p. 3–25
  2. Fisher DJ . Resurgence of rabies (a historical perspective on rabies in children) . Arch Pediatr Adolesc Med . 1995;149:306–312
  3. Bercovici K . Orphans as guinea pigs . The Nation . 1921;112:911–913
  4. Grodin MA . Historical origins of the Nuremberg Code . In:  Annas GJ ,  Grodin MA editor. The Nazi Doctors and the Nuremberg Code (Human Rights in Human Experimentation) . New York:: Oxford University Press; 1995;p. 121–144
  5. In: Permissible medical experiments (Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10) . Washington, DC: US Government Printing Office; 1949;p. 181–182 Nuremberg, October 1946-1949
  6. World Medical Association . Recommendations guiding medical doctors in biomedical research involving human subjects . Helsinki: 18th World Assembly; 1964; Revised 52nd WMA World General Assembly, Edinburgh, Scotland, 2000
  7. Advisory Committee on Human Radiation Experiments . The Human Radiation Experiments . New York: Oxford University Press; 1996;
  8. Moreno JD . Undue Risk (Secret State Experiments on Humans) . New York: Routledge; 2001;
  9. Experiments at Willowbrook . Lancet . 1971;1:1078–1079
  10. Ramsey P . Research involving children or incompetents . In:  Ramsey P editors. The Patient as Person (Explorations in Medical Ethics) . New Haven, CT: Yale University Press; 1970;p. 1–58
  11. Krugman S . Experiments at the Willowbrook State School . Lancet . 1971;1:966–967
  12. Krugman S . The Willowbrook hepatitis studies revisited (ethical aspects) . Rev Infect Dis . 1986;8:157–162
  13. Katz J . “Ethics and clinical research” revisited (a tribute to Henry K. Beecher) . Hastings Center Report . 1993;23:31–39
  14. Beecher HK . Ethics and clinical research . New Engl J Med . 1966;274:1354–1360
  15. Jonas H . Philosophical reflections on experimenting with human subjects . Daedalus . 1969;98:219–247
  16. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . Report and Recommendations (Research Involving Children) . Washington, DC: US Government Printing Office (DHEW publication); 1977;
  17. Bartholome WG . Ethical issues in pediatric research . In:  Vanderpool HY editors. The Ethics of Research Involving Human Subjects (Facing the 21st Century) . Hagerstown, MD: University Publishing Group; 1996;
  18. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research . The Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research) . Washington, DC: US Government Printing Office (DHEW publication); 1979;
  19. US Department of Health and Human Services . Federal policy for the protection of human subjects (Basic policy for the protection of human research subjects. (45 CFR 46)) . Federal Register . 1991;56:28012–28018 (June 18)
  20. Mish FC . Webster’s Ninth New Collegiate Dictionary . Springfield, MA: Merriam-Webster Inc; 1990;
  21. Emanuel EJ , Wendler D , Grady C . What makes clinical research ethical? . JAMA . 2000;283:2701–2711
  22. McCarthy AM , Richman LC , Hoffman RP , Rubenstein L . Psychological screening of children for participation in nontherapeutic invasive research . Arch Pediatr Adolesc Med . 2001;155:1197–1203
  23. US Department of Health and Human Services . Federal policy for the protection of human subjects (Additional protections for children involved as subjects in research. (45 CFR 46, Subpart D)) . Federal Register . 1983;48:9818–9820 (March 8)
  24. Tarnowski KJ , Allen DM , Mayhall C , Kelly PA . Readability of pediatric biomedical research informed consent forms . Pediatrics . 1990;85:58–62
  25. Waiver of informed consent requirements in certain emergency research . Federal Register . 1996;61:51531–51533
  26. Council on Ethical and Judicial Affairs, American Medical Association . Waiver of informed consent for research in emergency situations . In: Code of Medical Ethics (Current Opinions with Annotations) . 2002-2003 Edition.. Chicago, IL: AMA Press; 2002;p. 212–213
  27. Royal College of Paediatrics and Child Health, Ethics Advisory Committee . Guidelines for the ethical conduct of medical research involving children . Arch Dis Child . 2000;82:177–182
  28. Weithorn LA . Children’s capacity to decide about participation in research . IRB . 1983;5:1–5
  29. Weithorn LA , Scherer DG . Children’s involvement in research participation decisions (psychological considerations) . In:  Grodin MA ,  Glanz LH editor. Children as Research Subjects (Science, Ethics, and Law) . New York:: Oxford University Press; 1994;p. 133–180
  30. Denham EJ , Nelson RM . Self-determination is not an appropriate model for understanding parental permission and child assent . Anesth Analg . 2002;94:1049–1051
  31. Leikin S . Minors’ assent, or dissent to medical research . IRB . 1993;15:1–7
  32. Gaylin W . Competence (No longer all or none) . In:  Gaylin W ,  Macklin R editor. Who Speaks for the Child . New York: Plenum Press; 1982;p. 27–54
  33. Diekema DS . Taking children seriously (what’s so important about assent?) . Amer J Bioethics . 2003;3:25–26
  34. Diekema DS . Payments for participation of children in research . In:  Kodish E editors. Ethics and Research with Children (A Case-Based Approach) . New York: Oxford University Press; 2005;p. 143–160
  35. Wendler D , Rackoff J , Emanuel EJ , Grady C . The ethics of paying for children’s participation in research . J Pediatr . 2002;141:166–171
  36. American Academy of Pediatrics, Committee on Drugs . Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations . Pediatrics . 1995;95:286–294
  37. Fernhoff PM . Paying for children to participate in research (a slippery slope or an enlightened stairway?) . J Pediatr . 2002;141:153–154

PII: S0022-3476(06)00369-6

doi: 10.1016/j.jpeds.2006.04.043

The Journal of Pediatrics
Volume 149, Issue 1, Supplement , Pages S3-S11 , July 2006

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